How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the Pre-SPEC framework.

ABSTRACT: Results from clinical trials can be susceptible to bias if investigators choose their analysis approach after seeing trial data, as this can allow them to perform multiple analyses and then choose the method that provides the most favourable result (commonly referred to as 'p-hacking'). Pre-specification of the planned analysis approach is essential to help reduce such bias, as it ensures analytical methods are chosen in advance of seeing the trial data. For this reason, guidelines such as SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and ICH-E9 (International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) require the statistical methods for a trial's primary outcome be pre-specified in the trial protocol. However, pr

SUBMITTER: Kahan BC 

PROVIDER: S-EPMC7487509 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature